SAN FRANCISCO, Sept. 12, 2017 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR) today announced that it has begun
dosing in the PROPEL clinical study which will evaluate the
efficacy and safety of NKTR-214, the company's lead immuno-oncology
candidate in combination with approved checkpoint inhibitors,
TECENTRIQ® (atezolizumab) and KEYTRUDA®
(pembrolizumab). NKTR-214 is an investigational immuno-stimulatory
therapy designed to expand specific cancer-fighting T cells and
natural killer (NK) cells directly in the tumor microenvironment
and increase expression of PD-1 on these immune cells.
Atezolizumab is a monoclonal antibody designed to bind with
programmed death-ligand 1 (PD-L1). Pembrolizumab is an anti-PD-1
therapy that works by increasing the ability of the body's immune
system to help detect and fight tumor cells.
"NKTR-214 directly increases the numbers of tumor infiltrating
lymphocytes (TILs) in vivo and its unique
mechanism is designed to have synergy with all mechanisms of
checkpoint inhibition, including the PD-1/PD-L1 pathway," said
Mary Tagliaferri, M.D., Senior Vice
President of Clinical Development at Nektar Therapeutics. "The
PROPEL study is intended to show the synergies of NKTR-214 when
combined with either atezolizumab or pembrolizumab and it
complements our ongoing PIVOT clinical program which combines
NKTR-214 with nivolumab in eight different cancer indications. Many
patients fighting cancer lack sufficient TIL populations to benefit
from approved checkpoint inhibitor therapies and we believe the
combination of NKTR-214 with these agents could expand treatment
options for patients in multiple tumor settings."
NKTR-214 targets CD122 specific receptors found on the surface
of cancer-fighting immune cells in order to stimulate their
proliferation and activation. In clinical and preclinical
studies, treatment with NKTR-214 resulted in expansion of these
cells and mobilization into the tumor
micro-environment.1,2 NKTR-214 has an antibody-like
dosing regimen similar to the existing checkpoint inhibitor class
of approved medicines.
The Phase 1/2 PROPEL study is a Nektar-sponsored trial that will
enroll patients into two separate arms concurrently. The first
arm will evaluate an every three-week dose regimen of NKTR-214 in
combination with atezolizumab in up to 30 patients in approved
treatment settings of atezolizumab, including patients with
non-small cell lung cancer or bladder cancer. The second arm will
evaluate an every three-week dose regimen of NKTR-214 in
combination with pembrolizumab in up to 30 patients in approved
treatment settings of pembrolizumab, including patients with
melanoma, non-small cell lung cancer or bladder cancer.
About Nektar
Nektar Therapeutics is a research-based, development-stage
biopharmaceutical company whose mission is to discover and develop
innovative medicines to address the unmet medical needs of
patients. Our R&D pipeline of new investigational medicines
includes treatments for cancer, auto-immune disease and chronic
pain. We leverage Nektar's proprietary and proven chemistry
platform in the discovery and design of our new therapeutic
candidates. Nektar is headquartered in San
Francisco, California, with additional operations
in Huntsville, Alabama and Hyderabad, India.
Further information about the company and its drug development
programs and capabilities may be found online
at http://www.nektar.com.
TECENTRIQ is a registered trademark of Roche and KEYTRUDA is a
registered trademark of Merck & Co., Inc.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements which can
be identified by words such as: "intend," "plan," "expect,"
"believe," "should," "may," "will" and similar references to future
periods. Examples of forward-looking statements include, among
others, statements we make regarding the therapeutic potential of
NKTR-214, both alone and in combination with one or more other
agents (such as anti-PD1 and anti-PD-L1 agents), the synergistic
activities of combinations of active agents (such as NKTR-214 in
combination with anti-PD1 and anti-PD-L1 agents), the anticipated
timing of reporting data for our clinical studies, and the
potential of our technology and drug candidates in our research and
development pipeline. Forward-looking statements are neither
historical facts nor assurances of future performance. Instead,
they are based only on our current beliefs, expectations and
assumptions regarding the future of our business, future plans and
strategies, anticipated events and trends, the economy and other
future conditions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict and many of
which are outside of our control. Our actual results may differ
materially from those indicated in the forward-looking statements.
Therefore, you should not rely on any of these forward-looking
statements. Important factors that could cause our actual results
to differ materially from those indicated in the forward-looking
statements include, among others: (i) our statements regarding the
therapeutic potential of NKTR-214 are based on findings and
observations from preclinical findings and ongoing clinical
studies; (ii) NKTR-214, both alone and in combination with other
agents (such as anti-PD1 and anti-PD-L1 agents), is in early stages
of clinical development and the risk of failure remains high and
failure can unexpectedly occur due to efficacy, safety or other
unpredictable factors prior to regulatory approval for numerous
reasons, including negative safety and efficacy findings even after
positive findings in previous clinical and preclinical studies;
(iii) the timing of the commencement or end of clinical studies and
the availability of clinical data may be delayed or unsuccessful
due to regulatory delays, slower than anticipated patient
enrollment, manufacturing challenges, changing standards of care,
evolving regulatory requirements, clinical trial design, clinical
outcomes, competitive factors, or delay or failure in ultimately
obtaining regulatory approval in one or more important markets;
(iv) scientific discovery of new medical breakthroughs is an
inherently uncertain process and the future success of applying our
technology platform to potential new drug candidates (such as
NKTR-214) is therefore highly uncertain and unpredictable and one
or more research and development programs could fail; (v) patents
may not issue from our patent applications for our drug candidates
including NKTR-214, patents that have issued may not be
enforceable, or additional intellectual property licenses from
third parties may be required; and (vi) certain other important
risks and uncertainties set forth in our Quarterly Report on Form
10-Q filed with the Securities and Exchange
Commission on August 9, 2017. Any forward-looking
statement made by us in this press release is based only on
information currently available to us and speaks only as of the
date on which it is made. We undertake no obligation to update any
forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
Contact:
For Investors and Media:
Jennifer Ruddock of Nektar
Therapeutics
415-482-5585
Jodi Sievers of Nektar
Therapeutics
415-482-5593
- Charych, D., et al., Clin Can Res; 22(3) February 1,
2016
- Diab, A., et al., Journal for ImmunoTherapy of
Cancer 2016, 4(Suppl 1):P369
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SOURCE Nektar Therapeutics